A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test

NCT04191668 | Completed Results FDA Device

• 1 other identifier: NightOwl-01
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, the investigators will compare the respiratory event index (REI), defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the apnea-hypopnea index (AHI) obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. The investigators will also compare the total sleep time (TST) derived by both systems. This study will be performed in a sleep lab environment.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• Pearson Correlation Between the AHI

  The evaluation of the Pearson correlation between the apnea-hypopnea index (AHI) estimate obtained from the NightOwl and the AHI determined from the polysomnography (PSG); The AHI is defined as the number of apnea or hypopnea divided by the (estimated) total sleep time expressed in hours.

  Through study completion, an average of 1 month.

• Pearson Correlation Between the TST

  The evaluation of the Pearson correlation between the total sleep time (TST) estimate obtained from the NightOwl and the TST determined from the PSG;

  Through study completion, an average of 1 month.

• The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization

  The evaluation of the level agreement (classification accuracy) between patient categorization (into sleep apnea severity categories) obtained by the NightOwl and those obtained by the PSG. This measure is calculated by dividing the number of participants on which both NightOwl and the PSG agree on the sleep apnea severity category by the total number of participants.

  Through study completion, an average of 1 month.

Study Arms (1)

PSG and NightOwl

OTHER

Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.

Device: NightOwl

Interventions

NightOwl DEVICE

The NightOwl is a finger-mounted home sleep apnea testing device

PSG and NightOwl

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with an indication for an in-lab polysomnography

You may not qualify if:

• Intellectually disabled people
• People younger than 13 years of age.

Sponsors & Collaborators

• Ectosense NV: lead

Study Sites (3)

Miami Lakes Laboratory

Miami Lakes, Florida, 33016, United States

Location

Plantation Laboratory East

Plantation, Florida, 33324, United States

Location

Plantation Laboratory West

Plantation, Florida, 33324, United States

Location

Related Publications (2)

• Massie F, Vits S, Verbraecken J, Bergmann J. Context-aware analysis enhances autoscoring accuracy of home sleep apnea testing. J Clin Sleep Med. 2025 May 1;21(5):789-804. doi: 10.5664/jcsm.11534.

  PMID: 39748512 DERIVED

• Van Pee B, Massie F, Vits S, Dreesen P, Klerkx S, Bijwadia J, Verbraecken J, Bergmann J. A multicentric validation study of a novel home sleep apnea test based on peripheral arterial tonometry. Sleep. 2022 May 12;45(5):zsac028. doi: 10.1093/sleep/zsac028. Epub 2022 Feb 2.

  PMID: 35554589 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Frederik Massie
• Organization: Ectosense

frederik.massie@ectosense.com

+1 786 305 8547

Study Officials

• Frederik Massie, MSc

  Ectosense NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Sleep technician which analyses the PSG data will be blinded from any prior PSG analysis and the NightOwl analysis
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 10, 2019
• Study Start: December 2, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 30, 2021
• Results First Posted: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)